DETAILED ACTION
This action is in response to applicant’s election of Group I, Species I received on 5/12/2026. It is acknowledged that Claims 2-8, 11, 13-15 and 17-19 have been amended and new claims 20-24 added in the preliminary amendments received on 2/2/2024. Claims 9-20 and 24 are hereby withdrawn from further consideration. A complete action on the merits of claims 1-8 and 21-23 follows below.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Claims 9-20 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/12/2026.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-5, 7-8 and 21-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Srivastava (US Pub. No. 2015/0066006).
Regarding Claim 1, Srivastava teaches an intravascular medical device (Figs. 1-3B), comprising:
a support structure 108 defining a longitudinal axis and configured to be positioned within a vessel of a patient ([0023] Figs. 2-3B);
a plurality of focal energy sources 124/124a-d arranged around a perimeter of the support structure (Figs. 2-3B), wherein each of the plurality of focal energy sources is configured to deliver energy to one or more perivascular tissues near the vessel to heat the one or more perivascular tissues ([0023]-[0026] and [0032]); and
a plurality of temperature sensors arranged around the perimeter of the support structure, wherein each of the plurality of temperature sensors is configured to measure a temperature at or near a wall of the vessel (“one or more temperature (e.g., thermocouple, thermistor, etc.), impedance, pressure, optical, flow, chemical, neural signal, and/or other sensors, may be located proximate to, within, or integral with the energy delivery elements 124 . The sensor(s) and the energy delivery elements 124 can be connected to one or more supply wires (not shown) that transmit signals from the sensor(s) and/or convey energy to the energy delivery elements 124” [0026]).
Regarding Claim 2, Srivastava teaches wherein each of the plurality of temperature sensors is further configured to contact the wall of the vessel; and wherein the support structure 108 is configured to radially expand from a delivery configuration to a deployed position to cause the plurality of temperature sensors to contact the wall of the vessel (“one or more temperature (e.g., thermocouple, thermistor, etc.), impedance, pressure, optical, flow, chemical, neural signal, and/or other sensors, may be located proximate to, within, or integral with the energy delivery elements 124. The sensor(s) and the energy delivery elements 124 can be connected to one or more supply wires (not shown) that transmit signals from the sensor(s) and/or convey energy to the energy delivery elements 124” [0026] as seen in Figs. 1-3B as the neuromodulation elements 124 contact the wall of the vessel so do the sensors proximate to, within, or integral with the energy delivery elements 124).
Regarding Claim 4, Srivastava teaches wherein at least a portion of the plurality of focal energy sources 124 comprise a plurality of electrodes (“energy delivery elements 124 (e.g., electrodes)” [0022]) configured to: deliver a current to the wall of the vessel (Fig. 3B); and measure an impedance from the wall of the vessel, wherein the impedance represents an impedance of the one or more perivascular tissues ([0026]).
Regarding Claim 5, Srivastava teaches wherein each of the plurality of temperature sensors corresponds to a particular axial and circumferential position on the support structure (by providing a sensor associated with each delivery element 124, Figs. 1-3B), wherein the intravascular medical device is configured to output a temperature signal that includes a temperature measurement from each of the plurality of temperature sensors, and wherein each temperature measurement represents the temperature of the wall of the vessel at the respective axial and circumferential position on the support structure ([0026]).
Regarding Claim 7, Srivastava teaches further comprising an energy field generator 126 (Fig. 1) communicatively coupled to the plurality of focal energy sources 124 and configured to control the plurality of focal energy sources to deliver the energy to the one or more perivascular tissues ([0022], [0025] and [0032]).
Regarding Claim 8, Srivastava teaches wherein the energy field generator 126 (Fig. 1) is further configured to, in an ablation mode, control the plurality of focal energy sources to heat the one or more perivascular tissues above an ablation temperature of the one or more perivascular tissues ([0032]); and wherein the energy field generator is configured to: receive a temperature signal that includes a temperature measurement from each of the plurality of temperature sensors; and modify, based on the temperature signal, the energy delivered to at least one focal energy sources of the plurality of focal energy sources (“the energy delivery elements 124 may deliver power independently (i.e., may be used in a monopolar fashion), either simultaneously, selectively, or sequentially, and/or may deliver power between any desired combination of the energy delivery elements 124 (i.e., may be used in a bipolar fashion). In addition, an operator optionally may be permitted to choose which energy delivery element(s) 124 are used for power delivery in order to form highly customized lesion(s) within the renal artery, as desired. Additionally, one or more sensors (not shown), such as one or more temperature (e.g., thermocouple, thermistor, etc.), impedance, pressure, optical, flow, chemical, neural signal, and/or other sensors, may be located proximate to, within, or integral with the energy delivery elements 124. The sensor(s) and the energy delivery elements 124 can be connected to one or more supply wires (not shown) that transmit signals from the sensor(s) and/or convey energy to the energy delivery elements 124” [0026] also see [0029], [0069] and [0080]).
Regarding Claim 21, Srivastava teaches wherein each of the plurality of focal energy sources is independently operable ([0026]).
Regarding Claim 22, Srivastava teaches wherein the plurality of focal energy sources 124 comprises a plurality of radiofrequency electrodes ([0022], [0025] and “purposeful application of energy (e.g., RF energy) from the energy delivery elements 124 (FIG. 1) may then be applied to target tissue to induce one or more desired neuromodulating effects” [0032]).
Regarding Claim 23, Srivastava teaches wherein the energy field generator 126 is configured to, in an imaging mode, control the plurality of focal energy sources 124 to heat the one or more perivascular tissues below an ablation temperature of the one or more perivascular tissues (as it is unclear what an imaging mode is referring to and given the broadest reasonable interpretation, Mauch teaches visualizing the treatment procedure in [0031] as well as temperature control to maintain the temperature below an ablation temperature in [0032]).
Claims 1-4, 6-7 and 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mauch (US Pub. No. 2015/0359589).
Regarding Claim 1, Mauch teaches an intravascular medical device (Figs. 1, 6), comprising:
a support structure defining a longitudinal axis and configured to be positioned within a vessel of a patient ([0016] shown in different embodiments of Figs. 2-5B);
a plurality of focal energy sources 122/222 arranged around a perimeter of the support structure (Figs. 2-5B), wherein each of the plurality of focal energy sources is configured to deliver energy to one or more perivascular tissues near the vessel to heat the one or more perivascular tissues ([0017]-[0020]); and
a plurality of temperature sensors arranged around the perimeter of the support structure, wherein each of the plurality of temperature sensors is configured to measure a temperature at or near a wall of the vessel (“one or more sensors 22 located proximate to or within neuromodulation elements 122. For example, system 10 can include temperature sensors (e.g., thermocouples, thermistors, etc.)…” [0029]).
Regarding Claim 2, Mauch teaches wherein each of the plurality of temperature sensors is further configured to contact the wall of the vessel; and wherein the support structure is configured to radially expand from a delivery configuration to a deployed position to cause the plurality of temperature sensors to contact the wall of the vessel (“one or more sensors 22 located proximate to or within neuromodulation elements 122” [0029] as seen in Figs. 1, 3A-3B and 5A-5B as the neuromodulation elements 122 contact the wall of the vessel so do sensors 22 positioned located proximate to or within neuromodulation elements 122).
Regarding Claim 3, Mauch teaches further comprising an actuation assembly 19 configured to extend the plurality of temperature sensors through the wall of the vessel ([0023], [0030] and [0035]).
Regarding Claim 4, Mauch teaches wherein at least a portion of the plurality of focal energy sources 122/222 comprise a plurality of electrodes (“therapeutic assemblies include neuromodulation elements (e.g., energy delivery elements, band electrodes, etc.)…” [0016]) configured to: deliver a current to the wall of the vessel (“neuromodulation elements 122 are bipolar electrodes. Individual neuromodulation elements 122 are connected to energy generator 30 and are associated with proud portions 120 for directly contacting an internal wall of the artery (e.g., the renal artery). The application of RF electric field energy serves to ohmically or resistively heat tissue in the vicinity of the electrode and thereby thermally injures the heated tissue” [0028], also see [0050]); and measure an impedance from the wall of the vessel, wherein the impedance represents an impedance of the one or more perivascular tissues ([0019] and [0029]).
Regarding Claim 6, Mauch teaches wherein at least one of a spacing of adjacent temperature sensors of the plurality of temperature sensors is less than about 10 mm or an angular spacing of adjacent temperature sensors of the plurality of temperature sensors around the perimeter of the support structure is less than or equal to about 90 degrees ([0040] teaches the spacing between the electrodes and [0029] teaches “one or more sensors 22 located proximate to or within neuromodulation elements 122”).
Regarding Claim 7, Mauch teaches further comprising an energy field generator 30 (Fig. 1) communicatively coupled to the plurality of focal energy sources 122/222 and configured to control the plurality of focal energy sources to deliver the energy to the one or more perivascular tissues ([0022], [0025] and [0028]).
Regarding Claim 22, Mauch teaches wherein the plurality of focal energy sources 122/222 comprises a plurality of radiofrequency electrodes ([0022], [0025] and [0028]).
Regarding Claim 23, Mauch teaches wherein the energy field generator 30 is configured to, in an imaging mode, control the plurality of focal energy sources 122/222 to heat the one or more perivascular tissues below an ablation temperature of the one or more perivascular tissues (as it is unclear what an imaging mode is referring to and given the broadest reasonable interpretation, Mauch teaches visualizing the treatment procedure in [0042] and [0061] as well as temperature control to maintain the temperature below an ablation temperature in [0058] and [0062]).
Claims 1-2, 4-6 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by AGRAWAL (US Pub. No. 2014/0336637).
Regarding Claim 1, AGRAWAL teaches an intravascular medical device (Fig. 1), comprising:
a support structure (balloon 316 of catheter 310 in Figs. 4-5) defining a longitudinal axis and configured to be positioned within a vessel of a patient ([0004], [0029] and Fig. 1);
a plurality of focal energy sources (electrodes 318 sections) arranged around a perimeter of the support structure (Figs. 4-5), wherein each of the plurality of focal energy sources is configured to deliver energy to one or more perivascular tissues near the vessel to heat the one or more perivascular tissues ([0049]-[0056]); and
a plurality of temperature sensors 308 arranged around the perimeter of the support structure (Figs. 4-5), wherein each of the plurality of temperature sensors is configured to measure a temperature at or near a wall of the vessel ([0031]-[0032] and [0057]-[0060]).
Regarding Claim 2, AGRAWAL teaches wherein each of the plurality of temperature sensors 308 is further configured to contact the wall of the vessel (Figs. 4-5); and wherein the support structure 316 is configured to radially expand from a delivery configuration to a deployed position to cause the plurality of temperature sensors to contact the wall of the vessel ([0048] and [0059]).
Regarding Claim 4, AGRAWAL teaches wherein at least a portion of the plurality of focal energy sources 318 comprise a plurality of electrodes 314 configured to: deliver a current to the wall of the vessel ([0048]-[0049]); and measure an impedance from the wall of the vessel, wherein the impedance represents an impedance of the one or more perivascular tissues ([0037]).
Regarding Claim 5, AGRAWAL teaches wherein each of the plurality of temperature sensors 308 corresponds to a particular axial and circumferential position on the support structure 316 (Fig. 5), wherein the intravascular medical device is configured to output a temperature signal that includes a temperature measurement from each of the plurality of temperature sensors, and wherein each temperature measurement represents the temperature of the wall of the vessel at the respective axial and circumferential position on the support structure (Figs. 4-5 and [0058] and [0062]).
Regarding Claim 6, AGRAWAL teaches wherein at least one of a spacing of adjacent temperature sensors of the plurality of temperature sensors is less than about 10 mm or an angular spacing of adjacent temperature sensors of the plurality of temperature sensors around the perimeter of the support structure is less than or equal to about 90 degrees (Fig. 5).
Regarding Claim 22, AGRAWAL teaches wherein the plurality of focal energy sources comprises a plurality of radiofrequency electrodes ([0037] and [0049]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Srivastava as applied above in view of Mauch.
Regarding Claim 3, Srivastava teaches the invention as applied above and although an actuator is shown on the handle 110 in Fig. 1, Srivastava does not go in detail on what that actuator does. In the same field of invention, Mauch teaches “assembly 100 may be transformed between the delivery and deployed configurations using a variety of suitable mechanisms or techniques (e.g., self-expansion). In one specific example, support structure 110 can include a pre-formed, self-expanding tubular structure that tends to take on the deployed configuration when unconstrained (e.g., by retracting a guidewire, a guide catheter, straightening sheath, etc.). FIG. 1 illustrates a proximal end of a guidewire 50 extending from an exit port 15 in handle 18 and an actuator 19, such as a knob, pin, or lever carried by handle 18. Guidewire 50 and/or actuator 19 or other suitable mechanisms or techniques may be provided for transforming therapeutic assembly 100 between the delivery and deployed configurations” [0023]. Therefore, either the actuator shown in Fig. 1 of Srivastava is used for the same reason as actuator 19 of Mauch or alternatively it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use an actuation assembly similar to 19 configured to extend the plurality of temperature sensors through the wall of the vessel by transforming therapeutic assembly 100 between the delivery and deployed configurations as Mauch teaches.
Regarding Claim 6, Srivastava teaches the invention as applied above and although shows the spacing between the electrodes 124 in Figs. 1-3B, does not specifically teach wherein at least one of a spacing of adjacent temperature sensors of the plurality of temperature sensors is less than about 10 mm or an angular spacing of adjacent temperature sensors of the plurality of temperature sensors around the perimeter of the support structure is less than or equal to about 90 degrees. Mauch teaches the spacing between the electrodes in [0040] and in view of [0029] teaching “one or more sensors 22 located proximate to or within neuromodulation elements 122”, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to have at least one of a spacing of adjacent temperature sensors of the plurality of temperature sensors is less than about 10 mm so that the edges of the lesions formed by individual neuromodulation elements 122 on the inner wall of renal artery RA are overlapping or non-overlapping. Referring to FIG. 3B depending on the procedure as Mauch teaches in [0040].
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Mauch as applied above in view of AGRAWAL (US Pub. No. 2014/0336637).
Regarding Claim 5, Mauch broadly teaches “reliable radial and longitudinal contact of the electrodes with the inner wall of the target blood vessel may provide benefits, such as more reliable energy transmission, which may lower energy requirements and improve the accuracy of impedance and temperature measured at the inner wall of the target blood vessel” in [0019] and although states “one or more sensors 22 located proximate to or within neuromodulation elements 122” [0029], it is at most unclear if each of the neuromodulation elements 122 (electrodes) includes a sensor wherein each of the plurality of temperature sensors 22 corresponds to a particular axial and circumferential position on the support structure, wherein the intravascular medical device is configured to output a temperature signal that includes a temperature measurement from each of the plurality of temperature sensors, and wherein each temperature measurement represents the temperature of the wall of the vessel at the respective axial and circumferential position on the support structure.
In the same field of invention AGRAWAL teaches “sensors 308 formed within the optical fiber 302 to be positioned over the balloon 316 in such a way that they are adjacent to, in contact with, or meet the virtual electrodes 318. Such a configuration of the optical fiber 302 may enable a more accurate monitoring of temperature at an interface where the tissue meets the virtual electrode 318 during an ablation procedure” in [0058].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to include a temperature sensor adjacent to, in contact with or within each of the electrodes in order for the intravascular medical device to be configured to output a temperature signal that includes a temperature measurement from each of the plurality of temperature sensors, and wherein each temperature measurement represents the temperature of the wall of the vessel at the respective axial and circumferential position on the support structure where each electrode is positioned in contact with tissue at the area for a more accurate temperature reading of the area during the procedure.
Claims 8 and 21 rejected under 35 U.S.C. 103 as being unpatentable over Mauch as applied above in view of Srivastava.
Regarding Claim 8, Mauch teaches wherein the energy field generator 30 is further configured to, in an ablation mode, control the plurality of focal energy sources to heat the one or more perivascular tissues above an ablation temperature of the one or more perivascular tissues ([0062], [0068]-[0069]); and although Mauch broadly teaches “one or more sensors 22 located proximate to or within neuromodulation elements 122” [0029], it is at most unclear if each of the neuromodulation elements 122 (electrodes) includes a sensor wherein each of the plurality of temperature sensors 22, it is at most unclear if the energy field generator is configured to: receive a temperature signal that includes a temperature measurement from each of the plurality of temperature sensors; and modify, based on the temperature signal, the energy delivered to at least one focal energy sources of the plurality of focal energy sources.
Srivastava teaches “the energy delivery elements 124 may deliver power independently (i.e., may be used in a monopolar fashion), either simultaneously, selectively, or sequentially, and/or may deliver power between any desired combination of the energy delivery elements 124 (i.e., may be used in a bipolar fashion). In addition, an operator optionally may be permitted to choose which energy delivery element(s) 124 are used for power delivery in order to form highly customized lesion(s) within the renal artery, as desired. Additionally, one or more sensors (not shown), such as one or more temperature (e.g., thermocouple, thermistor, etc.), impedance, pressure, optical, flow, chemical, neural signal, and/or other sensors, may be located proximate to, within, or integral with the energy delivery elements 124. The sensor(s) and the energy delivery elements 124 can be connected to one or more supply wires (not shown) that transmit signals from the sensor(s) and/or convey energy to the energy delivery elements 124” [0026] also see [0032], [0069] and [0080] discussing temperature based treatment control.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to allow the user to select each of the energy delivery elements 122 of Mauch to independently be activated in order to form a highly customized lesion(s) as well as allow temperature control procedures.
Regarding Claim 21, Mauch teaches wherein each of the plurality of focal energy sources is independently coupled to the energy source ([0028], [0050]), Srivastava teaches where each of the plurality of focal energy sources is independently operable ([0026] of Srivastava).
Conclusion
Other reference made of record, but not relied on is: AGRAWAL (US Pub. No. 2014/0336637) teaching an intravascular medical device (Fig. 1), comprising: a support structure (balloon 316 of catheter 310 in Figs. 4-5) defining a longitudinal axis and configured to be positioned within a vessel of a patient ([0004], [0029] and Fig. 1); a plurality of focal energy sources (electrodes 318 sections) arranged around a perimeter of the support structure (Figs. 4-5), wherein each of the plurality of focal energy sources is configured to deliver energy to one or more perivascular tissues near the vessel to heat the one or more perivascular tissues ([0049]-[0056]); and a plurality of temperature sensors 308 arranged around the perimeter of the support structure (Figs. 4-5), wherein each of the plurality of temperature sensors is configured to measure a temperature at or near a wall of the vessel ([0031]-[0032] and [0057]-[0060]).
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
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